ADVIA DIFF TIMEpac 120, 2120i, 2120 (2019-06-28)

Starting date:

June 28, 2019

Posting date:

July 15, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70419

Last updated: 2019-07-15

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  Reason
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  Affected products

Affected Products

A. ADVIA 120 DIFF TIMEpac

B. ADVIA 2120i DIFF TIMEpac

C. ADVIA 2120 DIFF TIMEpac

Reason

Siemens Healthcare Diagnostics has confirmed that platelet clump flags (PLT-CLM) may be generated in the perox channel of the ADVIA 120/2120/2120i Hematology System while running CBC/DIFF (complete blood count / differential) whole blood samples with DIFF TIMEpac reagent lot numbers 94414, 94415 and 31129, in samples without platelet clumps. ADVIA 120/2120/2120i DIFF TIMEpac lot numbers 94414, 94415 and 31129 contain perox 1 reagent lot 94412. The accuracy of the platelet results is not impacted when the perox 1 reagent (lot number 94412) is used on the system and a PLT-CLM flag may be generated due to this issue. Additionally, platelet results are reported from the red blood cell/platelet (RBC/PLT) channel and not measured in the perox channel where platelet clumps are detected. However, the platelet results will be flagged if the clump count is greater than 300, directing the user to investigate the sample.

Affected products